Posted by Michael Wonder on 17 Apr 2017
Enzyvant receives FDA breakthrough therapy designation and regenerative medicine advanced therapy designation for investigational therapy RVT-802
17 April 2017 - Enzyvant anticipates potential BLA filing in the first half of 2018.
Enzyvant today announced that the U.S. FDA has granted RVT-802, Enzyvant's investigational tissue-based therapy for the treatment of complete DiGeorge Syndrome, breakthrough therapy designation as well as regenerative medicine advanced therapy designation.
Both designations confer special access to the Office of Tissues and Advanced Therapies for development guidance as well as expedited review pathways.
